DOTAREM (GADOTERATE MEGLUMINE)
Summary
FDA approved DOTAREM (GADOTERATE MEGLUMINE) by GUERBET. NDA (New Drug) approval (Labeling) on 2025-03-05. SOLUTION, INTRAVENOUS.
Details
Source
Drug Approval
External ID
NDA204781-17
Action Date
2025-03-05
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
DOTAREM (generic: GADOTERATE MEGLUMINE), SOLUTION, INTRAVENOUS. Application: NDA204781
Company
Context & Analysis
GUERBET has 2 FDA actions in our database.
Frequently Asked Questions
How often does GUERBET have FDA actions?
GUERBET has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA204781-17" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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